N
Patient 1
(B)(4).
MAUDE MDR 9279420
- MDR report key
- 9279420
- Report number
- 9681900-2019-00049
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-09
- Date received
- 2019-11-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- VICTORIA SANDLIN
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LMA SUPREME SIZE 1.5 | LMA SUPREME | TELEFLEX MEDICAL | CAE | 175015 | LMCA2N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-05 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER REPORTED THE DEVICE BROKE IN THE PATIENT'S MOUTH DURING INTUBATION. THE DEVICE DID NOT SEPARATE INTO TWO PIECES, AS THE GASTRIC TUBE WAS CONNECTING IT. IT WAS REPORTED THE PATIENT WAS BAGGED WHILE A NEW DEVICE WAS PREPARED AND INTUBATED. NO PATIENT INJURY REPORTED. PATIENT CONDITION WAS REPORTED AS "FINE".